MelanomaPhase 2NCT00162123
A Companion Study for Patients Enrolled in Prior/Parent Ipilimumab Studies
A Phase 2 study testing Ipilimumab in people with Melanoma, run by Bristol-Myers Squibb at 58 sites in 18 countries.
Trial summary
The purpose of this study was to evaluate the continued use of ipilimumab in patients who had reinduction at the time of disease progression or to continue maintenance treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Ipilimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 58 sitesin 18 countries
- Study dates
- May 2006to Apr 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of advanced melanoma
- Prior treatment in a prespecified prior/parent ipilimumab study
- Men and women 18 years of age and older
- First Reinduction:
- No unacceptable toxicity (except select reversible immune-related adverse events) requiring ipilimumab discontinuation
- Had experienced documented progressive disease after expanded clinical benefit
Show all 12Show fewer
- Extended Maintenance
- Received ipilimumab at any dose in a parent study
- Achieved expanded clinical benefit at the time of entry to current study
- Follow-up:
- Received ipilimumab at any dose in a closing parent study
- Deemed ineligible for reinduction or extended maintenance treatment or refused treatment as reinduction or extended maintenance at the time of screening in the current study, but consented to follow-up
Who cannot join
- Prior treatment with a CD137 agonist or a cytotoxic T-lymphocyte antigen 4 inhibitor or agonist, other than ipilimumab
- Primary ocular or mucosal melanoma
Trial locations and contacts
58 sites in 18 countries.
58 sites in 18 countries
United States19 sites
Carolinas Medical Center
Charlotte, North Carolina, 28203
University Of Chicago
Chicago, Illinois, 60637
The Christ Hospital Cancer Center Research
Cincinnati, Ohio, 45219
Center For Oncology Research & Treatment, P.A.
Dallas, Texas, 75230
Cancer Centers Of The Carolinas
Greenville, South Carolina, 29615
Indiana Oncology Hematology Consultants
Indianapolis, Indiana, 46202
Baptist Cancer Institute
Jacksonville, Florida, 32207
Wilshire Oncology Medical Group Inc
Laverne, California, 91750
The Angeles Clinic & Research Inst.
Los Angeles, California, 90025
Usc/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Joe Arrington Cancer Research And Treatment Center
Lubbock, Texas, 79410
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Providence Portland Medical Center
Portland, Oregon, 97213
St Joseph Oncology Inc
Saint Joseph, Missouri, 64507
San Francisco Oncology Associates
San Francisco, California, 94115
University Of Washington Medical Center
Seattle, Washington, 98109
Washington University School Of Medicine
St Louis, Missouri, 63110
Local Institution
To Come, Connecticut
University Of Arizona Cancer Center
Tucson, Arizona, 85719
France4 sites
Local Institution
Brest, 29200
Local Institution
Lyon, 69373
Local Institution
Paris, 75010
Local Institution
Vandœuvre-lès-Nancy, 54511
Italy4 sites
Local Institution
Genova, 16132
Local Institution
Meldola (Fc), 47014
Local Institution
Rimini, 47900
Local Institution
Siena, 53100
Belgium3 sites
Local Institution
Brussels, 1070
Local Institution
Brussels, 1090
Local Institution
Brussels, 1200
Brazil3 sites
Local Institution
Jaú, São Paulo, 17210
Local Institution
Porto Alegre, Rio Grande do Sul, 90050
Local Institution
Porto Alegre, Rio Grande do Sul, 90610
Canada3 sites
Local Institution
Calgary, Alberta, T2N 4N2
Local Institution
Edmonton, Alberta, T6G 1Z2
Local Institution
Moncton, New Brunswick, E1C 6Z8
Germany3 sites
Local Institution
Berlin, D-12200
Local Institution
Heidelberg, 69120
Local Institution
Kiel, D-24105
Poland3 sites
Local Institution
Lodz, 90553
Local Institution
Poznan, 61-866
Local Institution
Wroclaw, 51-124
Russia3 sites
Local Institution
Saint Petersburg, 191104
Local Institution
Stavropol, 355047
Local Institution
Voronezh, 394000
Israel2 sites
Local Institution
Jerusalem, 91120
Local Institution
Tel Aviv, 64239
South Africa2 sites
Local Institution
Cape Town, Western Cape, 7570
Local Institution
Johannesburg, Gauteng, 2199
About this study
Official title: A Multi-Center, Open-Label, Phase II Study of Ipilimumab (MDX-010 Extended-Treatment Monotherapy or Follow-up for Patients Previously Enrolled in Ipilimumab (MDX-010) Protocols.
The purpose of this study was to evaluate the continued use of ipilimumab in patients who had reinduction at the time of disease progression or to continue maintenance treatment. In addition, this study will continue to follow patients who have taken ipilimumab, but who are not eligible for maintenance or reinduction therapy.
- Conditions
- Melanoma
- Being tested
- Ipilimumab
- Keywords
- ipilimumab, previously treated
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpilimumabDrug
Also called BMS-734016, MDX-010
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
| Study group | Role | What they receive |
|---|---|---|
| First reinduction: Ipilimumab, 0.3 to 10 mg/kg | Experimental | Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study. Receives: Drug: Ipilimumab |
| First reinduction: Ipilimumab, 3 to 10 mg/kg | Experimental | Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study. Receives: Drug: Ipilimumab |
| First reinduction: Ipilimumab, 10 to 10 mg/kg | Experimental | Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study. Receives: Drug: Ipilimumab |
| Extended maintenance: Ipilimumab, 0.3 mg/kg | Experimental | Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent. Receives: Drug: Ipilimumab |
| Extended maintenance: Ipilimumab, 3 mg/kg | Experimental | Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent. Receives: Drug: Ipilimumab |
| Extended maintenance: Ipilimumab, 10 mg | Experimental | Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent. Receives: Drug: Ipilimumab |
| Follow-up | No intervention | Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With On-study Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related AEs, Immune-related AEs (irAEs), and Death as Outcome
An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. An SAE is a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related is defined as having certain, probable, possible, or missing relationship to study drug. An IrAE is an AE characterized by a potential association with inflammation and considered by the investigator to be drug related. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
Measured: Continuously from first dose to 70 days after last dose of study drug. For deaths, Day 1 of enrollment to 70 days after last dose of study drug.
Secondary outcomes (4)
Overall Survival (OS)
OS was computed for all patients who entered this study and is defined as the time between the first dose of study therapy and death. If a patient has not died, OS was censored at the time of last contact.
Measured: From first dose of study drug in parent study to death or date of last censoring.
Percentage of Participants Surviving at 1, 1.5, and 2 Years
Survival rate was defined as the time from first dose of study drug to 1, 1.5, and 2 years.
Measured: From first dose of study drug in parent study to up to 2 years after reinduction
Number of Participants With On-study Immune-related Adverse Events (irAEs)
irAEs were defined as adverse events characterized by a potential association with inflammation and considered by the investigator as drug related. These prespecified terms were grouped into the following organ-specific subcategories: gastrointestinal, hepatic, skin, endocrine, neurologic, and other (includes blood, eye, immune system, investigations, infections, renal, and respiratory systems). Patients may have 1 or more events.
Measured: From first dose of study drug during reinduction to the earliest of 70 days after last dose or day before second reinduction first dose date
Progression-free Survival (PFS)
PFS was defined as the time between the date of the baseline tumor assessment in this study and the date of progression or death, whichever occurred first.
Measured: From day of first reinduction in current study to date of progression or death, whichever occurred first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startMay 2006
- Primary completionSep 2012
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00162123
- Sponsor's protocol ID
- CA184-025
- Status last verified
- Jun 2016
- First submitted
- 9 Sep 2005
- Last updated
- 27 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lebbe C, Weber JS, Maio M, Neyns B, Harmankaya K, Hamid O, O'Day SJ, Konto C, Cykowski L, McHenry MB, Wolchok JD. Survival follow-up and ipilimumab retreatment of patients with advanced melanoma who received ipilimumab in prior phase II studies. Ann Oncol. 2014 Nov;25(11):2277-2284. doi: 10.1093/annonc/mdu441. Epub 2014 Sep 10.
PubMed 25210016
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open-Label, Phase II Study of Ipilimumab (MDX-010 Extended-Treatment Monotherapy or Follow-up for Patients Previously Enrolled in Ipilimumab (MDX-010) Protocols.
- ClinicalTrials.gov ID
- NCT00162123
- Acronym / sponsor ID
- CA184-025
- Conditions
- Melanoma
- Keywords
- ipilimumab, previously treated
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Sep 2012 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 13 Sep 2005 (estimated)
- Results
- Posted 15 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the continued use of ipilimumab in patients who had reinduction at the time of disease progression or to continue maintenance treatment. In addition, this study will continue to follow patients who have taken ipilimumab, but who are not eligible for maintenance or reinduction therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| First reinduction: Ipilimumab, 0.3 to 10 mg/kg | Experimental | Drug: IpilimumabParticipants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study. |
| First reinduction: Ipilimumab, 3 to 10 mg/kg | Experimental | Drug: IpilimumabParticipants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study. |
| First reinduction: Ipilimumab, 10 to 10 mg/kg | Experimental | Drug: IpilimumabParticipants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study. |
| Extended maintenance: Ipilimumab, 0.3 mg/kg | Experimental | Drug: IpilimumabParticipants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent. |
| Extended maintenance: Ipilimumab, 3 mg/kg | Experimental | Drug: IpilimumabParticipants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent. |
| Extended maintenance: Ipilimumab, 10 mg | Experimental | Drug: IpilimumabParticipants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent. |
| Follow-up | No intervention | –Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Diagnosis of advanced melanoma
- Prior treatment in a prespecified prior/parent ipilimumab study
- Men and women 18 years of age and older
- No unacceptable toxicity (except select reversible immune-related adverse events) requiring ipilimumab discontinuation
- Had experienced documented progressive disease after expanded clinical benefit
Key exclusion criteria (2 listed)
- Prior treatment with a CD137 agonist or a cytotoxic T-lymphocyte antigen 4 inhibitor or agonist, other than ipilimumab
- Primary ocular or mucosal melanoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IpilimumabAlso: BMS-734016, MDX-010Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation | Drug | Extended maintenance: Ipilimumab, 0.3 mg/kg, Extended maintenance: Ipilimumab, 10 mg, Extended maintenance: Ipilimumab, 3 mg/kg, First reinduction: Ipilimumab, 0.3 to 10 mg/kg, First reinduction: Ipilimumab, 10 to 10 mg/kg, First reinduction: Ipilimumab, 3 to 10 mg/kg |
Primary outcome
Number of Participants With On-study Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related AEs, Immune-related AEs (irAEs), and Death as Outcome
Time frame: Continuously from first dose to 70 days after last dose of study drug. For deaths, Day 1 of enrollment to 70 days after last dose of study drug.
An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. An SAE is a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related is defined as having certain, probable, possible, or missing relationship to study drug. An IrAE is an AE characterized by a potential association with inflammation and considered by the investigator to be drug related. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
4 secondary outcomes
Overall Survival (OS)
Time frame: From first dose of study drug in parent study to death or date of last censoring.
Percentage of Participants Surviving at 1, 1.5, and 2 Years
Time frame: From first dose of study drug in parent study to up to 2 years after reinduction
Number of Participants With On-study Immune-related Adverse Events (irAEs)
Time frame: From first dose of study drug during reinduction to the earliest of 70 days after last dose or day before second reinduction first dose date
Progression-free Survival (PFS)
Time frame: From day of first reinduction in current study to date of progression or death, whichever occurred first.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25210016Lebbe C, Weber JS, Maio M, Neyns B, Harmankaya K, Hamid O, O'Day SJ, Konto C, Cykowski L, McHenry MB, Wolchok JD. Survival follow-up and ipilimumab retreatment of patients with advanced melanoma who received ipilimumab in prior phase II studies. Ann Oncol. 2014 Nov;25(11):2277-2284. doi: 10.1093/annonc/mdu441. Epub 2014 Sep 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
58 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ipilimumab in people with Melanoma, run by Bristol-Myers Squibb at 58 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in United States, France, Italy, Belgium, Brazil and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With On-study Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related AEs, Immune-related AEs (irAEs), and Death as Outcome (time frame: Continuously from first dose to 70 days after last dose of study drug. For deaths, Day 1 of enrollment to 70 days after last dose of study drug.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00162123, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2016.